GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

NCT00110721 | Terminated Phase 2

• 1 other identifier: DAVFU-003
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 6

Brief Summary

This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; DAVANAT; 5-fluorouracil

Outcome Measures

Primary Outcomes (2)

• frequency of objective complete or partial tumor response

  Tumor response as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

  20 patients completed treatment

• frequency of stable disease

  Stable disease as measured by CT imaging or carcinoembryonic antigen (CEA) levels

  20 patients completed treatment

Secondary Outcomes (1)

• safety of GM-CT-01 plus 5-FU

  20 patients completed treatment

Interventions

GM-CT-01 plus 5-Fluorouracil DRUG

Single use vials, combined regimen of GM-CT-01 / 5-Fluorouracil (280 mg/m2 /500 mg/m2) given for 4 consecutive days in a 28 day cycle until disease progression.

Also known as: DAVANAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Has a histologically-proven adenocarcinoma of the colon or rectum
• Has documentation of locally advanced or metastatic colorectal cancer not amenable to curative surgery or radiotherapy
• Eligible subjects are those whose unresectable, locally advanced and/or metastatic colorectal cancer has progressed during or after receiving treatment with at least two, but not more than three, lines of therapy that collectively must have included at a minimum all of the following agents: 5-fluorouracil or capecitabine, irinotecan, and oxaliplatin (unless, in the opinion of the investigator, the subject is not able to receive irinotecan and/or oxaliplatin due to medical contraindications, in which case irinotecan and/or oxaliplatin are not required to have been included in the prior lines of therapy). Adjuvant chemotherapy following definitive management of the primary lesion in the colon or rectum is allowed and will not be counted as a line of therapy.
• Has 1 or more measurable lesion(s) ("target lesion\[s\]") according to RECIST (Response Evaluation Criteria in Solid Tumors) criteria.
• The same diagnostic imaging method must be used throughout the study to evaluate the lesions; and clinically detected lesions will only be considered measurable when they are superficial (e.g., skin nodules and palpable lymph nodes).
• Has an ECOG performance status of 0-2
• Has a life expectancy greater than 3 months
• Has the ability to understand the nature of the study and any hazards of participating in it; to communicate satisfactorily with the Investigator; and to participate in, and comply with, the requirements of the entire study
• A female of childbearing potential must have a negative serum screening test for pregnancy and agree to practice abstinence or use an effective method of contraception
• Has had all aspects of the protocol explained and written informed consent obtained

You may not qualify if:

• Has central nervous system metastasis
• Has bony metastasis as the sole metastasis
• Has other concomitant or previous malignancy in the past 3 years, except:
• adequately treated in situ carcinoma of the uterine cervix;
• basal or squamous cell carcinoma of the skin; and/or
• melanoma in situ.
• Is receiving concomitant anti-neoplastic treatment; has received radiation therapy in the past 3 weeks; has been treated with anti-angiogenesis agents, including bevacizumab, in the past 4 weeks; or has been treated with any other chemotherapeutic agents in the past 4 weeks (6 weeks for mitomycin C and nitrosoureas).
• Has an active infection
• Has congestive heart failure (Class III or IV in the New York Heart Association functional classification system)
• Has a hemoglobin level of \< 8.5 gm/dL
• Has a platelet count of \< 100,000/mm3
• Has a neutrophil count of \< 1,500/mm3
• Has a serum creatinine level of \> 2.0 mg/dL
• Has liver aminotransferase and alkaline phosphatase levels that are \> 2.5 times the laboratory's upper limit of normal (ULN) in a subject with no liver metastases, and levels that are \> 5 times the laboratory's ULN in a subject with liver metastases
• Has a total bilirubin level that is \> 2 times the laboratory's ULN

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (6)

Medical Oncology and Hematology

Waterbury, Connecticut, 06708, United States

Location

Hematology-Oncology Associates of the Treasure Coast

Port Saint Lucie, Florida, 34952, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Location

Soroka University Medical Center

Beersheba, 84101, Israel

Location

Shaare Zedek Medical Center, Oncology

Jerusalem, 91031, Israel

Location

Related Links

• Sponsor's website

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

galactomannan; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2005
• First Posted: May 13, 2005
• Study Start: May 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: February 1, 2008
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

US (4); IL (2)